Idorsia Pharmaceuticals Ltd
Drug Safety Physician(m/w/x)
Full-timeOn-siteSenior
Allschwil
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IDIdorsia Pharmaceuticals Ltd
Drug Safety Scientist(m/w/x)
Allschwil
Full-timeOn-siteSenior
Nejo AI Summary
Leading signal management and preparing periodic safety reports for small-molecule drugs, including insomnia treatment QUVIVIQ™. 10+ years pharmacovigilance experience in pharma, with 3+ years writing regulatory safety documents, required. International exposure in a European biotech.
Requirements
- University degree in life science (e.g., pharmacy, nursing, M.Sc., Ph.D.) or equivalent health-related education
- At least 10 years pharmacovigilance experience in pharmaceutical industry
- Excellent medical writing skills
- At least 3 years experience writing regulatory safety documents (e.g., DSURs, PBRERs/PSURs, ISS, clinical study reports)
- Solid knowledge of clinical trial and post-marketing regulatory safety regulations and guidelines (ICH, EU, FDA)
- Excellent communication skills
- Excellent interpersonal skills
- Excellent problem-solving skills
- Strong organizational skills
- Ability to work within tight timelines
- Effective project management skills
- Effective English communication (verbal and written)
- Excellent knowledge of MedDRA coding thesauri, SMQs, WHO drug dictionary, and SDGs
- Strong analytical skills
- Attention to details
Tasks
- Lead signal management activities.
- Plan and prepare periodic safety reports (e.g., DSUR, PBRER).
- Support Drug Safety Physician in analyzing and reviewing safety data.
- Support Drug Safety Physician in analyzing and reviewing product safety profiles.
- Provide expertise on global pharmacovigilance regulations and guidelines.
- Support Drug Safety Physician in evaluating identified safety signals.
- Support Drug Safety Physician in preparing responses to HA safety queries.
- Lead safety signal tracking and management.
- Track and document new safety signals.
- Ensure oversight of signal activities.
- Ensure timely completion of safety measures and actions.
- Monitor PRAC meeting documents and relevant sources.
- Inform Drug Safety Physician of relevant safety information.
- Inform Head of GDS of relevant safety information.
- Coordinate planning and responsibility allocation for periodic safety reports.
- Coordinate submission of periodic safety reports to HAs.
- Collaborate with departments on aggregated safety report preparation.
- Ensure accurate and timely departmental contributions to safety reports.
- Lead medical writing of periodic and ad-hoc safety analysis reports.
- Cooperate with Drug Safety Physician on medical writing.
- Review medical and scientific literature for safety reports.
- Collaborate with DRA on timely regulatory submission of safety reports.
- Support Drug Safety Physician in preparing filing and submission documents (e.g., ISS, RSI, RMP).
- Mentor Safety Scientists or related functions.
- Act as MedDRA expert.
- Develop, update, and maintain specifications for data retrieval and analysis.
- Stay current on pharmacovigilance regulations and guidance.
- Ensure SOPs and Work Instructions are updated and compliant.
- Lead improvement initiatives for signal management and periodic safety reports.
- Serve as expert for HA inspections on signal management and periodic safety reports.
- Serve as expert for HA audits on signal management and periodic safety reports.
Work Experience
- 10 years
Education
- Vocational certification
Languages
- English – Business Fluent
Tools & Technologies
- MedDRA
- SMQs
- WHO drug dictionary
- SDGs
Benefits
Learning & Development
- Professional growth and learning
Informal Culture
- Collaborative culture
- International exposure
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Idorsia Pharmaceuticals Ltd and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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IDIdorsia Pharmaceuticals Ltd
Drug Safety Scientist(m/w/x)
Allschwil
Full-timeOn-siteSenior
Nejo AI Summary
Leading signal management and preparing periodic safety reports for small-molecule drugs, including insomnia treatment QUVIVIQ™. 10+ years pharmacovigilance experience in pharma, with 3+ years writing regulatory safety documents, required. International exposure in a European biotech.
Requirements
- University degree in life science (e.g., pharmacy, nursing, M.Sc., Ph.D.) or equivalent health-related education
- At least 10 years pharmacovigilance experience in pharmaceutical industry
- Excellent medical writing skills
- At least 3 years experience writing regulatory safety documents (e.g., DSURs, PBRERs/PSURs, ISS, clinical study reports)
- Solid knowledge of clinical trial and post-marketing regulatory safety regulations and guidelines (ICH, EU, FDA)
- Excellent communication skills
- Excellent interpersonal skills
- Excellent problem-solving skills
- Strong organizational skills
- Ability to work within tight timelines
- Effective project management skills
- Effective English communication (verbal and written)
- Excellent knowledge of MedDRA coding thesauri, SMQs, WHO drug dictionary, and SDGs
- Strong analytical skills
- Attention to details
Tasks
- Lead signal management activities.
- Plan and prepare periodic safety reports (e.g., DSUR, PBRER).
- Support Drug Safety Physician in analyzing and reviewing safety data.
- Support Drug Safety Physician in analyzing and reviewing product safety profiles.
- Provide expertise on global pharmacovigilance regulations and guidelines.
- Support Drug Safety Physician in evaluating identified safety signals.
- Support Drug Safety Physician in preparing responses to HA safety queries.
- Lead safety signal tracking and management.
- Track and document new safety signals.
- Ensure oversight of signal activities.
- Ensure timely completion of safety measures and actions.
- Monitor PRAC meeting documents and relevant sources.
- Inform Drug Safety Physician of relevant safety information.
- Inform Head of GDS of relevant safety information.
- Coordinate planning and responsibility allocation for periodic safety reports.
- Coordinate submission of periodic safety reports to HAs.
- Collaborate with departments on aggregated safety report preparation.
- Ensure accurate and timely departmental contributions to safety reports.
- Lead medical writing of periodic and ad-hoc safety analysis reports.
- Cooperate with Drug Safety Physician on medical writing.
- Review medical and scientific literature for safety reports.
- Collaborate with DRA on timely regulatory submission of safety reports.
- Support Drug Safety Physician in preparing filing and submission documents (e.g., ISS, RSI, RMP).
- Mentor Safety Scientists or related functions.
- Act as MedDRA expert.
- Develop, update, and maintain specifications for data retrieval and analysis.
- Stay current on pharmacovigilance regulations and guidance.
- Ensure SOPs and Work Instructions are updated and compliant.
- Lead improvement initiatives for signal management and periodic safety reports.
- Serve as expert for HA inspections on signal management and periodic safety reports.
- Serve as expert for HA audits on signal management and periodic safety reports.
Work Experience
- 10 years
Education
- Vocational certification
Languages
- English – Business Fluent
Tools & Technologies
- MedDRA
- SMQs
- WHO drug dictionary
- SDGs
Benefits
Learning & Development
- Professional growth and learning
Informal Culture
- Collaborative culture
- International exposure
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Idorsia Pharmaceuticals Ltd and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Idorsia Pharmaceuticals Ltd
Industry
Pharmaceuticals
Description
Idorsia is a biopharmaceutical company focused on discovering, developing, and commercializing transformative medicines.
Not a perfect match?
- Idorsia Pharmaceuticals Ltd
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Full-timeOn-siteSeniorAllschwil - Roche
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Full-timeOn-siteExperiencedBasel - Novartis
Global Program Safety Team Lead(m/w/x)
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Global Senior Pharmacovigilance QA Manager(m/w/x)
Full-timeOn-siteSeniorBasel - Novartis
Global Program Safety Lead(m/w/x)
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